Abstract

Currently, great significance is attached to the preparation of diagnostic drugs based on specific immunoreagents, which include monoclonal antibodies produced by hybridomas. The use of monoclonal antibodies is one of the important approaches for the detection of pathogens of particularly dangerous infections – anthrax, brucellosis, tularemia, plague, cholera, glanders, and melioidosis. The review presents the main achievements of Russian scientists on obtaining such experimental drugs, and also pays attention to those sets of monoclonal reagents that are authorized in the Russian Federation. To date, three sets of reagents for detecting the causative agent of anthrax (latex agglutination, immunochromatographic method, multiplex immunofluorescence analysis) have been registered in our country on the basis of monoclonal antibodies; four sets of reagents for identifying the causative agent of tularemia (latex agglutination, immunochromatographic method, multiplex immunofluorescence analysis, dot-variant of enzyme immunoassay); three sets for the detection of plague microbe (enzyme immunoassay and immune chromatographic tests); five sets for cholera vibrios (slide agglutination, immunofluorescence, immune chromatographic method and enzyme immunoassay); two sets for the diagnosis of glanders and melioidosis (immunofluorescence); kits for detecting brucella have not been registered, there are only singular experimental designs. The involvement of modern drugs based on monoclonal antibodies in the diagnosis of particularly dangerous infections will improve the quality and reliability of laboratory analysis.

Highlights

  • Great significance is attached to the preparation of diagnostic drugs based on specific immunoreagents, which include monoclonal antibodies produced by hybridomas

  • The involvement of modern drugs based on monoclonal antibodies in the diagnosis of dangerous infections will improve the quality and reliability of laboratory analysis

  • Иващенко с соавт. [35] на основе пары Моноклональные антитела (МКА) 5G6 и 2B8 сконструирована иммуноферментная моноклональная тест-система для выявления V-антигена, которая также успешно прошла межлабораторные медицинские испытания на базе Иркутского противочумного института, что позволило рекомендовать ее в качестве альтернативы или в дополнение к другим диагностическим методам

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Summary

Introduction

Заслуживают внимания и экспериментальные тест-системы: иммуноферментная (ИФА) и магноиммуносорбентная (МИС) для выявления возбудителя сибирской язвы в споровой форме, которые успешно прошли комиссионные испытания, но не зарегистрированы в качестве медицинских изделий. Подобный набор реагентов зарегистрирован для определения возбудителей сибирской язвы и туляремии методом мультиплексного иммунофлуоресцентного анализа (тест-система ИФЛА-2BF). На сегодняшний день в нашей стране зарегистрированы четыре набора реагентов на основе МКА: три набора производства ФБУН ГНЦ ПМБ – для определения возбудителя туляремии в реакции латекс-агглютина­ ции (ФСР 2011/12157), с помощью иммунохроматографической тест-системы (ФСР 2009/05486) и методом мультиплексного иммунофлуоресцентного анализа (РЗН 2014/1468), а также тест-система «ДИАТул-М» (ФСР 2012/13944) производства ФКУЗ РосНИПЧИ «Микроб», позволяющая выявлять F. tularensis в дот-варианте ИФА.

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